ASV for Sleep Apnea After Myocardial Infarction (TEAM-ASV-I)

September 14, 2021 updated by: Michael Arzt, University Hospital Regensburg

Treatment of Sleep Apnea Early After Myocardial Infarction With Adaptive Servo-Ventilation - a Randomized Controlled Trial

The aim of this randomized controlled trial is to test the effect of 12 weeks Adaptive Servo-Ventilation (ASV) therapy (additionally to optimal medical management of myocardial infarction) on myocardial salvage (MSI=myocardial salvage/area at risk, primary endpoint).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Primary Outcome Measure: myocardial salvage index, MSI

- To test the effect of 12 weeks of ASV (additionally to percutaneous coronary intervention, PCI, and optimal medical management of AMI) on myocardial salvage (myocardial salvage index, MSI, assessed by cardiovascular magnetic resonance imaging, CMR).

Secondary Outcome Measures:

- To test whether ASV therapy in patients with SA early after AMI decreases infarct size and improves left ventricular remodelling (myocardial salvage, microvascular obstruction change of infarct size, infarct size at 12 weeks, change of left ventricular ejection fraction (LVEF), left ventricular systolic volume (LVSV), left ventricular diastolic volume (LVDV) and LVEF at 12 weeks; assessed with CMR).

B-type natriuretic peptide (NT-proBNP)

  • To test whether ASV therapy in patients with SA early after AMIimproves disease specific symptom burden (Seattle Angina Questionnaire)
  • To test whether ASV therapy in patients with sleep apnea early after AMI suppresses sleep apnea (apneas and hypopneas/hour of sleep, mean oxygen saturation).
  • To test whether ASV therapy in patients with sleep apnea early after AMI increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula).

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW
      • Berlin, Germany, 12683
        • Unfallkrankenhaus Berlin
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg
      • Regensburg, Germany, 93053
        • University Hospital Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age 18-80 years
  2. first AMI (ST-elevation in ECG or acute occlusion of coronary artery)
  3. Primary successful PCI achieved <24 h after symptom onset
  4. SA with an AHI >=15 per hour recording time
  5. written informed consent

Exclusion criteria:

  1. previous myocardial infarction
  2. previous myocardial revascularization (PCI or surgical)
  3. LVEF <45% and central sleep apnea
  4. indication for a surgical revascularisation
  5. cardiogenic shock, mean supine blood pressure <60mmHg or NYHA class IV
  6. implanted cardiac device or other contraindications for CMR
  7. known allergies or other contraindication to contrast medium (e.g. GFR<30ml/min/1.73m²)
  8. history of stroke
  9. contraindications for positive airway pressure support (hypotension with mean supine BP <60mmHg, dehydration, inability to clear secretions, patients at risk for aspiration of gastric contents, severe bullous lung disease, history of pneumothorax and/or pneumomediastinum, a history of epistaxis, causing pulmonary aspiration of blood, cerebrospinal fluid leak or recent skull operations or injury) patients on or with indication for oxygen therapy, mechanical/non-invasive ventilation
  10. patients on nocturnal positive airway pressure support
  11. severe obstructive or restrictive airway disease
  12. heart failure due to primary valve disease
  13. patients awaiting heart transplantation
  14. diurnal symptoms of OSA requiring immediate treatment
  15. pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology alone
Active Comparator: Adaptive servo-ventilation
optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology plus treatment of sleep apnea with adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia). Dose: The optimal ASV settings will be determined during 1-2 nights monitored by polygraphy within 5 days after PCI.
Device: Adaptive servo-ventilation
Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia)
Other Names:
  • ASV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial salvage index, MSI
Time Frame: 12 weeks
To test the effect of 12 weeks of ASV (additionally to percutaneous coronary intervention, PCI, and optimal medical management of AMI) on myocardial salvage (myocardial salvage index, MSI, assessed by cardiovascular magnetic resonance imaging, CMR).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infarct size and left ventricular remodelling
Time Frame: 12 weeks
To test whether ASV therapy in patients with SA early after AMI decreases infarct size and improves left ventricular remodelling (myocardial salvage, microvascular obstruction change of infarct size, infarct size at 12 weeks, change of left ventricular ejection fraction (LVEF), left ventricular systolic volume (LVSV), left ventricular diastolic volume (LVDV) and LVEF at 12 weeks; assessed with CMR).
12 weeks
B-type natriuretic peptide (NT-proBNP)
Time Frame: 12 weeks
To test whether ASV therapy in patients with SA early after AMI reduces B-type natriuretic peptide (NT-proBNP).
12 weeks
disease specific symptom burden
Time Frame: 12 weeks
To test whether ASV therapy in patients with SA early after AMIimproves disease specific symptom burden (Seattle Angina Questionnaire)
12 weeks
suppresses sleep apnea
Time Frame: 12 weeks
To test whether ASV therapy in patients with sleep apnea early after AMI suppresses sleep apnea (apneas and hypopneas/hour of sleep, mean oxygen saturation).
12 weeks
renal function
Time Frame: 12 weeks
increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Regensburg

Collaborators

ResMed Foundation

Investigators

  • Principal Investigator: Michael Arzt, MD, University Hospital Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol Version 6.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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